Trial Committee Manager
Job Summary
The Trial Committee Manager oversees the end-to-end management of clinical trial committees (IDMC Safety Review Committee Adjudication Committee etc.) that provide unbiased oversight and expert guidance throughout the lifecycle of clinical this role you will serve as the central point of coordination for sponsors committee members and cross-functional PSI teams ensuring committee activities are executed efficiently compliantly and to the highest quality standards. You will collaborate with global project teams and external experts to support the successful delivery of clinical trials across a variety of therapeutic areas.
You will be responsible for:
- Managing the full lifecycle of clinical trial committees from committee setup and member selection through study conduct and close-out.
- Coordinating committee meetings communications recommendations and follow-up activities throughout the course of clinical trials.
- Developing maintaining and updating committee charters procedures and other trial-specific documentation.
- Identifying evaluating and engaging qualified external committee members based on study requirements expertise availability and independence criteria.
- Performing Fair Market Value assessments and preparing honorarium estimates for independent committee members.
- Supporting audits and inspections related to committee management activities and contributing to corrective and preventive actions as needed.
- Contributing to the development and continuous improvement of committee-related quality documentation business processes templates and training materials.
- Supporting the planning and delivery of internal training on committee management processes.
Qualifications :
- Bachelors degree in Life Sciences Pharmacy Healthcare Clinical Research or a related field.
- At least 3 years of experience in clinical research preferably within a CRO environment.
- Experience managing or coordinating clinical trial committees or comparable experience in clinical trial management with exposure to committee processes.
- Proven project management and stakeholder coordination skills with the ability to manage multiple priorities in a fast-paced environment.
- Strong organizational communication and problem-solving skills with exceptional attention to detail.
- Ability to build effective working relationships with sponsors external experts and cross-functional teams.
- Professional proficiency in English (written and spoken).
- Proficiency in Microsoft Office applications and virtual meeting platforms.
Additional Information :
Join a collaborative globally connected team dedicated to ensuring the highest standards of independent clinical trial this role youll work closely with sponsors renowned external experts and cross-functional teams to facilitate unbiased committee governance that supports critical decisions throughout the clinical trial lifecycle.
If youre passionate about clinical research thrive in a highly organized stakeholder-facing environment and enjoy coordinating complex projects that make a real impact on the quality of clinical trials wed love to hear from you.
Remote Work :
Yes
Employment Type :
Full-time
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more